The Effect of Intrathecal Magnesium Sulfate on Shivering

Not Applicable

Completed

• Conditions: Magnesium Sulfate Causing Adverse Effects in Therapeutic Use; Postoperative Shivering; Cesarean Section Complications
• Interventions: Drug: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)

• Registration Number: NCT05427149
• Lead Sponsor: Yuzuncu Yıl University

Brief Summary

Shivering after spinal anesthesia is a common complication. Mangesium sulfate, which can be used intrathecally, is effective in preventing tremor. But what is the ideal dose?

Detailed Description

Perioperative shivering during cesarean section (CS) under neuraxial anesthesia (NA) is clinically common, but its treatment is often neglected.

When the literature is scanned, perioperative tremors are seen in 55%-60% of patients undergoing neuraxial anesthesia. However, the mechanism of the tremor has not been fully elucidated. Possible factors that can cause tremor can be listed as follows:

1. Loss of thermoregulatory vasoconstriction below the block level,

2. The displacement of body temperature from the central to the periphery due to vasodilation,

3. Increased sweating threshold and decreased peripheral vasoconstriction Perioperative shivering is a complication that needs to be treated because it causes dangerous consequences in patients with low cardiopulmonary reserve due to increased oxygen consumption and impairs patient and surgeon comfort.

Magnesium sulfate is one of the most effective adjuvant drugs with the least side-effect profile in the treatment of tremor after noxial block.

Study Timeline

• Study Start: 2022-05-10
• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-06-15
• Study First Posted: 2022-06-22
• Primary Completion: 2022-06-30
• Study Completion: 2022-08-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-23
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Who were scheduled for elective C/S under SA,
• 18-40 years of age
• ASA physical status I-II.

Exclusion Criteria

• Any contraindications to SA,
• preoperative body temperature >38 C,
• allergy to any drug used in the study,
• pre-eclampsia, and eclampsia,
• neuropathy,
• respiratory distress,
• coagulopathy, and
• any possible drugs that can change body temperature,
• ASA physical status > II.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)	Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 1 mL normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey)
Group M25	25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)	Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey). MgSO4 diluted to 25mg/mL with normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey).
Group M50	25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)	Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 50 mg/mL MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey). MgSO4 diluted to 50mg/mL with normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey).
Group M100	25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)	Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 100 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey). MgSO4 diluted to 100mg/mL with normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey)

Primary Outcome Measures

Name	Time	Method
Level of shivering	3 mounths	Intraoperative and postoperative shivering will be evaluated with the shivering test established by Crossley and Mahajan.; flicker tracking; The parameters looked at in this test approved by Crossley and Mahajan are: 0 = no flicker,; 1. = Piloerection or peripheral vasoconstriction, but no visible shivering,; 2. = Muscle activity in only 1 muscle group,; 3. = more muscle activity than 1 muscle group but not generalized; 4. = Full body shivering

Trial Locations

Locations (1)

Van yuzuncu Yıl University, Dursun Odabas Medical Center; 🇹🇷 Van, Turkey